NA 9626-07-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295243311), received between Mar 12, 2020 and May 2, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Crack” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED: I HAVE NOT BEEN MADE AWARE OF ANY ADVERSE EVENT TO A PATIENT ARISING BECAUSE OF THIS MATTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229378 ↗
• MalfunctionDec 20, 2022Crack; Crack

  I¿VE HAD AN EMAIL FROM BMI LINCOLN REPORTING THAT ONE OF THEIR CEMENTED CUP PUSHERS HAS A CRACK IN ITS HANDLE AFTER REPEATED REPROCESSING SO THEIR TSSU WILL NOT LONGER PROCESS. THERE WAS NO IMPACT TO SURGERY OR THE PATIENT AND THE ITEM HAS BEEN DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16013587 ↗
• MalfunctionApr 13, 2022Crack; Crack

  IT WAS REPORTED THAT CRACK IN THE HANDLE, DISCOVERED DURING INSTRUMENTS CHECK BY SALES REPRESENTATIVE. NO DELAY TO SURGERY BECAUSE OF THE ABOVE. I NOTED IT, NOT THE ACCOUNT, SO NOT REPORTED BY THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102314 ↗
• MalfunctionNov 25, 2020Crack; Crack

  THE TWO INSTRUMENTS ARRIVED THE HOSPITAL WITH CRACK IN THE PLASTIC WHERE / WHEN DID THE EVENT OCCUR? OTHER ARRIVED WITH CRACK WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE HAS NOT BEEN IN USE WAS A PATIENT INVOLVED: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10900500 ↗
• MalfunctionNov 25, 2020Crack; Crack

  THE TWO INSTRUMENTS ARRIVED THE HOSPITAL WITH CRACK IN THE PLASTIC. WHERE / WHEN DID THE EVENT OCCUR? OTHER ARRIVED WITH CRACK. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE HAS NOT BEEN IN USE. WAS A PATIENT INVOLVED: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10900386 ↗
• MalfunctionNov 25, 2020Crack; Contamination /Decontamination Problem; Crack; Contamination /Decontamination Problem

  HAS PRODUCT BEEN POTENTIALLY CONTAMINATED OR IS CONTAMINATED WITH BODILY FLUIDS? YES, CRACK IN PLASTIC. THIS COMPLAINT IS ABOUT AN INSTRUMENT, WHICH ONLY HAS BEEN USED IN THE WASHING MACHIN, AND A CRACK APPEARED IN THE PLASTIC. WHERE / WHEN DID THE EVENT OCCUR? POST - OP. WAS A PATIENT INVOLVED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10899700 ↗
• MalfunctionMar 12, 2020Crack; Crack

  A COMPLAINT ON AN INSTRUMENT WHICH HAS NOT BEEN USED. CRACK IN THE PLASTIC DURING WASHING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9824112 ↗